Category Archives: Food and Drug Administration

Smith’s Food and Drug Stores recall In-store Bakery Carrot Cake

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smith-food-drugNATIONAL — Smith’s Food and Drug Stores said today it is recalling select Smith’s Bakery Fresh Carrot Cake sold in 7 states because the product contains walnuts that may not be listed on the label.

Item Description:
Smith’s Bakery Fresh Carrot Cake, 1/4 sheet filled.  Packaged on or before April 1, 2015.  UPC Code: 41573-07058
Smith’s Bakery Fresh Carrot Cake Slice, 5 oz.  Packaged on or before April 1, 2015. UPC Code: 750903-91714
Smith’s Bakery Fresh Carrot Cake, 1/8 Sheet.  Packaged on or before April 1, 2015. UPC Code: 770118-22460

carrot-cakeCustomers should return the product to stores for a full refund.

People who are allergic to walnuts could have a serious or life-threatening reaction if they consume this product. For consumers who are not allergic to walnuts, there is no safety issue with the product.

No customer illnesses have been reported to date.

Store Locations:
Smith’s stores in the following states are included in this recall: Utah, Nevada, Arizona, New Mexico, Montana, Idaho, and Wyoming

Smith’s removed items from store shelves and initiated a customer recall notification system that alerts customers who may have purchased recalled Class 1 products through register receipt tape messages and phone calls.

Customers who have questions about this recall may contact Smith’s Customer Connect toll-free at 800-576-4377. For more information, please visit www.smithsfoodanddrug.com/recall_alertsdisclaimer icon

Aurora Products, Inc. Recalls Certain Walnuts and Trail Mixes Due to Possible Health Risk

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Orange, CT — Aurora Products, Inc. is conducting a voluntary nationwide recall of certain lots of NATURAL WALNUTS and TRAIL MIXES CONTAINING WALNUTS because they have the potential to contain Salmonella which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

Product was distributed nationwide through retail stores. Product was also distributed in Canada and Bermuda.

No illnesses have been reported to date.

Aurora is communicating with stores that have received the affected product. Stores have been instructed to cease distribution of these products and to remove the affected product from store shelves.

The affected products were produced by Aurora Products, Inc. The potential for contamination was noted after routine testing by an outside company contracted by the FDA revealed the presence of Salmonella in one container of natural walnuts product. Organic walnuts are not affected.

Consumers that have the products listed below are urged to not eat it and destroy the product or return it to the point of purchase. Customers with questions can contact Aurora Products, Inc. for further information at (800)-898-1048 between the hours of 9:00AM to 5:00 PM EST Monday – Friday.
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Kraft Foods Group Voluntarily Recalls Select Kraft Macaroni & Cheese Boxed Dinners Due to Possible Metal Pieces

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ucm438726NORTHFIELD, Ill. — Kraft Foods Group is voluntarily recalling approximately 242,000 cases of select code dates and manufacturing codes of the Original flavor of Kraft Macaroni & Cheese Dinner – due to the possibility that some boxes may contain small pieces of metal. The recalled product is limited to the 7.25-oz. size of the Original flavor of boxed dinner with the “Best When Used By” dates of September 18, 2015 through October 11, 2015, with the code “C2” directly below the date on each individual box. The “C2” refers to a specific production line on which the affected product was made.

Some of these products have also been packed in multi-pack units that have a range of different code dates and manufacturing codes on the external packaging (box or shrink-wrap), depending on the package configuration (see table below).

Recalled product was shipped to customers in the U.S. and several other countries, excluding Canada. The affected dates of this product were sold in only these four configurations:

  • 7.25 oz. box, Original flavor
  • 3-pack box of those 7.25 oz. boxes, Original flavor
  • 4-pack shrink-wrap of those 7.25 oz. boxes, Original flavor
  • 5-pack shrink-wrap of those 7.25 oz. boxes, Original flavor

The following is being recalled:

Product Size Name of Product Sell Unit Best When Used By Code Date & Mfr. Code Individual Box Best When Used By Code Date & Mfr. Code Individual Box UPC Multi-Pack Unit UPC
7.25 oz. each Kraft Macaroni & Cheese Boxed Dinner
Original Flavor		 NA 18 SEP 2015 C2
through
11 OCT 2015 C2		 0 21000 65883 1 NA
3-Pack Box
(Three 7.25 oz. Boxes)
Net Wt. 21.75 oz.		 3-Pack Kraft Macaroni & Cheese Boxed Dinner
Original Flavor		 09 SEP 2015 XDG
27 SEP 2015 XDG
01 OCT 2015 XDG
02 OCT 2015 XDG
03 OCT 2015 XDG
20 NOV 2015 XDG		 18 SEP 2015 C2
through
11 OCT 2015 C2		 0 21000 65883 1 0 21000 05076 5
4-Pack
Shrink–wrap
(Four 7.25 oz. Boxes)
Net Wt. 29 oz.		 4-Pack Kraft Macaroni & Cheese Boxed Dinner
Original Flavor		 18 SEP 2015 C2
19 SEP 2015 C2
08 OCT 2015 C2		 18 SEP 2015 C2
through
11 OCT 2015 C2		 0 21000 65883 1 0 21000 72540 3
5-Pack
Shrink-wrap
(Five 7.25 oz. Boxes)
Net Wt. 36.25 oz.		 5-Pack Kraft Macaroni & Cheese Boxed Dinner
Original Flavor		 18 SEP 2015
through
11 OCT 2015
XAR or C2		 18 SEP 2015 C2
through
11 OCT 2015 C2		 0 21000 65883 1 0 21000 77436 4

No other sizes, varieties or pasta shapes and no other packaging configurations are included in this recall. And no products with manufacturing codes other than “C2” below the code date on the individual box are included in this recall.

Kraft has received eight consumer contacts about this product from the impacted line within this range of code dates and no injuries have been reported. We deeply regret this situation and apologize to any consumers we have disappointed.

The recalled product was shipped by Kraft to customers nationwide in the U.S. The product was also distributed to Puerto Rico and some Caribbean and South American countries — but not to Canada.

Consumers who purchased this product should not eat it. They should return it to the store where purchased for an exchange or full refund. Consumers also can contact Kraft Foods Consumer Relations at 1-800-816-9432 between 9 am and 6 pm (Eastern) for a full refund.

Frontier Co-op Initiates Voluntary Class 1 Recall Due to Possible Health Risk from Organic Garlic Powder

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recall-3Frontier Co-op is voluntarily recalling several of its products manufactured with organic garlic powder that were sold under its Frontier and Simply Organic brands, and one product sold under the Whole Foods Market brand due to potential Salmonella contamination. To date, no illnesses have been associated with these products.

The product in question was raw material received by Frontier, which tested positive for Salmonella during a test by the United States Food and Drug Administration. Given that Salmonella may be present, Frontier is immediately initiating this recall.

Frontier Co-op is immediately initiating added precautions to the safety of the supply chain and instituting additional product testing, beyond FDA guidelines, to mitigate any future occurrence.

Consumption of products containing Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea, nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections, endocarditic and arthritis.

Recalled products were sold in all 50 states and in some parts of Canada to distributors, retailers and consumers. Below the release is a list of products containing the organic garlic powder. Images of the affected products can be viewed at the following link: http://www.frontiercoop.com/recalldisclaimer icon.

On foil bulk packages, the four-digit lot code will be found on the front label directly above the UPC code. On bottled items, the four-digit lot code can be found on the bottom of the bottle. On seasoning mixes, the four-digit lot code is embossed on the right side of the packet.

Consumers should not consume these products and should either throw away any remaining products or return to the point of purchase for a refund.

Please contact Frontier Co-op with any questions or to inquire about replacement or reimbursement at 1- 800-669-3275 Monday through Friday from 8:00 a.m. to 5:00 p.m. Central time.
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Primal Pet Foods Voluntarily Recalls A Single Lot of Raw Frozen Cat Food

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300-PrimalPrimal Pet Foods is voluntarily recalling a single batch production code of Feline Turkey Raw Frozen Formula 3-pound bag. FDA tested product in response to a single consumer complaint. Primal Pet Foods was alerted by FDA that the testing of two bags of this lot resulted in a low thiamine level. Neither FDA nor Primal have received any other reports concerning Thiamine in Primal products. No other product manufactured by Primal Pet Foods is involved in this voluntary recall.

Cats fed only diets low in thiamine for several weeks may be at risk for developing a thiamine deficiency. Thiamine is essential for cats. Symptoms of deficiency displayed by an affected cat can be gastrointestinal or neurological in nature. Early signs of thiamine deficiency may include decreased appetite, salivation, vomiting, and weight loss. In advanced cases, neurologic signs can develop, which may include ventriflexion (bending towards the floor) of the neck, wobbly walking, circling, falling, and seizures. If your cat has consumed the recalled lot and has these symptoms, please contact your veterinarian. If treated promptly, thiamine deficiency is typically reversible.

Only the product with the following Best By date and production code is included in the voluntary recall. It is best to check the production code on the back of the bag to determine if the product has been recalled or not.

The lot involved in this voluntary recall is:

Primal Pet Foods Feline Turkey Raw Frozen Formula 3-pound bag (UPC# 8 50334-00414 0) with Best By date 060815 B22

Primal takes very seriously, the need for adequate Thiamine levels in our feline diets. We include Organic Quinoa Sprout Powder as a natural B-Complex supplement to ensure that adequate levels of Thiamine are met. Additionally, Thiamine occurs naturally in other ingredients contained in our Feline Turkey Formula such as: Turkey Muscle Meat (including heart), Turkey Liver, Organic Sunflower Seeds, Dried Organic Kelp, Organic Collard Greens and Organic Squash.

Consumers who still have bags of cat food from this lot should stop feeding it to their cats and call us at (866) 566-4652 Monday through Friday, 9:00 am – 4:00 pm PST. Consumers with further questions should visit our website at www.primalpetfoods.com or call us at this same number.

Urgent: El Popocatepetl Ind., Inc. issues an allergy alert on Sundried Tomato, Spinach Pesto, and Chipotle Wraps

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wraps-1

El Popocatepetl Ind., Inc. of Chicago, Illinois is voluntarily recalling El Popocatepetl’s 8 in. Chipotle, Spinach Pesto, and Sun Dried Tomato Wraps because they may contain undeclared milk and Yellow #5. People who have allergies to milk and/or Yellow #5 run the risk of serious or life-threatening allergic reaction if they consume these products.

El Popocatepetl’s 8in. Flavored Wraps were distributed in the state of Illinois, primarily in the Chicago area.

The information on how the recalled products can be identified is listed below:

Product Name: 8in. Sundried Tomato
Brand Name: El Popocatepetl
Description: 8in. Tomato Flavored Wrap
UPC: 0 20784 99505 7
Any Product with the Best By Date of
April 1, 2015 and Before.
Product Name: 8in. Spinach Pest
Brand Name: El Popocatepetl
Description: 8in. Spinach Flavored Wrap
UPC: 0 20784 58314 8
Any Product with the Best By Date of
April 1, 2015 and Before.
Product Name: 8in. Chipotle
Brand Name: El Popocatepetl
Description: 8in. Chipotle Flavored Wrap
UPC: 0 20784 78248 0
Any Product with the Best By Date of
April 1, 2015 and Before.

The recall was initiated during a review of the product ingredients and the labeled ingredients revealed milk and Yellow #5 was present in an ingredient used to make the flavored wraps but not listed as ingredients on the labels. No Illnesses have been reported to date.

All recalled products are being removed from the store shelves. No other El Popocatepetl products are involved in this recall.

Consumers who have purchased the recalled product can return it to the place of purchase for a full refund. Consumers with questions may contact the Company Consumer Department at 773-843-0888.

Hummingbird Wholesale Issues Allergy Alert on Undeclared Milk in Organic Chocolate Hazelnut Butter

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hummingbird-1WASHINGTON — Hummingbird Wholesale in Eugene Oregon is recalling 110 jars of Hummingbird Brand Organic Chocolate Hazelnut Butter that may contain undeclared milk. People who have an allergy or severe sensitivity to milk products run the risk of serious or life threatening allergic reaction if they consume this product.

No illnesses have been reported to date.

The recalled product sold to retail outlets in California, Oregon, and Washington and directly to consumers in Oregon in 1 pound (454 gram) glass jars that show lot number of 15023 on a white sticker on the jar between the dates of 1/27/15 and 2/19/15.

HW Item # Lot # UPC Code
N270 15023 6-96859-11035-1

The recall was initiated after it was discovered that a supplier had changed the ingredients without notice to include milk in the 65% dark chocolate used to make the Organic Chocolate Hazelnut Butter. The label does not show milk as an ingredient. Only lot # 15023 was made with the affected chocolate.

Consumers who purchased this product are welcome to return it to the place of purchase for a full refund, or to contact Hummingbird at 541-686-0921 ext. 105 from 8am to 4pm PST Monday through Friday.

This recall is being made with the knowledge of the U.S. Food and Drug Administration.

Hummingbird Wholesale has taken immediate action to recall the affected Organic Chocolate Hazelnut Butter in order to ensure the safety of its consumers.

Hummingbird Wholesale is dedicated to providing the highest quality organic and raw products, and the safety of our customers is our number one priority.

ESS Food Recalls Pork Products Produced Without Benefit of Import Inspection

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USDA-RECALL-1WASHINGTON – ESS Food, a Danish establishment, is recalling approximately 50,904 pounds of pork belly product produced in Poland that was not presented at the U.S. point of entry for inspection, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. Without the benefit of full inspection, a possibility of adverse health consequences exists.

The boneless pork belly was produced on various dates from March 3, 2014 to April 11, 2014. The following product is subject to recall:

Approximately 40-lb. boxes containing 4-5 pieces of “PINI POLONA PORK BELLY BONELESS”

The products subject to recall bear the establishment number “10023802” inside the Polish mark of inspection. The products were shipped to a distributor in Texas and a processing facility in Iowa.

The problem was discovered during routine surveillance of storage facilities when an FSIS investigator observed that the products lacked USDA import inspection marks.

This is a Class I Recall which indicates a health hazard situation where there is a reasonable probability that the use of the product will cause serious, adverse health consequences or death.

FSIS and the company have received no reports of adverse reactions due to consumption of these products. Anyone concerned about a reaction should contact a healthcare provider.

Consumers or Media with questions about the recall can contact Michael Stentebjerg, Area Manager, at (404) 254-8510.

Detox Transforms Health and Nutrition Issues Voluntary Nationwide Recall of Dietary Supplements

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dextrol-recallDetox Transforms Health and Nutrition, Garner, NC announced it is conducting a voluntary recall of the following dietary supplements, to the consumer level, because they contain undeclared drug ingredients making them unapproved drugs.

Product Name Bottle Color Label # Capsules UPC Lot Expiration
EDGE Amplified Weight Release White Purple label 60 852175004174 ALL
iNDiGO White Dark blue label 60 852175004044 000034 4/10/2017
AMPD Gold Bee Pollen White Black label 60 852175004181 ALL
BtRim Max White Dark Red label 60 852175004068 00002 4/27/2017
iNSANE Bee Pollen White Bright Red label 60 852175004082 0000:02 6/20/2017

FDA analysis found iNDiGO and BtRim Max to contain undeclared phenolphthalein. The health risks of phenolphthalein could include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use. FDA analysis found EDGE Amplified Weight Release and iNSANE Bee Pollen to contain undeclared phenolphthalein and fluoxetine. In addition to the potential adverse health consequences for phenolphthalein, the concomitant use of fluoxetine with other medications such as MAO-Inhibitors and serotonin precursors (such as tryptophans) is either contraindicated or is not recommended. Fluoxetine is an SSRI with potentially life-threatening side effects that is given to patients to treat depression, anxiety, panic attacks, obsessive-compulsive disorder, or bulimia. Even when taken as prescribed, fluoxetine has been associated with serious side effects including suicidal thinking, abnormal bleeding, and seizures. Thus, any adverse reaction that is possible with fluoxetine is possible with the fluoxetine-containing dietary supplement product. In patients on other medications for common conditions (aspirin, ibuprofen, or other drugs for depression, anxiety, bipolar illness, blood clots, chemotherapy, heart conditions, and psychosis), ventricular arrhythmia or sudden death can occur with concomitant use of fluoxetine. FDA analysis found AMPD Gold Bee Pollen to contain undeclared sildenafil which has the potential to interact with medications. Males taking nitrates are at risk for life threatening hypotensive events. Certain medications such as ritonavir, ketoconazole, and itraconazole as well as consuming substantial amounts of alcohol can increase the effects of sildenafil.

The products were distributed nationwide via the internet and retail stores. No illnesses have been reported to date with the use of these products.

Detox Transforms has ceased distribution of the products as the company is working in close cooperation with the U.S. Food and Drug Administration (FDA) to fully resolve this issue. Detox Transforms is notifying its distributors and customers by email, telephone, and mail and is arranging for return of all recalled products. Consumers/distributors/retailers that have these products which are being recalled should stop use and return to place of purchase for a full refund.

Consumers with questions regarding this recall may contact Detox Transforms at 877-404-7873 or 919-341-9050 between the hours of 10am – 6pm (EST), Monday through Friday. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with these of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Safeway Recalls Safeway Select French Salted Caramel (Fleur De Sel) Premium Ice Cream

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safeway-select-ice-cream-18489PLEASANTON, Calif. — Safeway is voluntarily recalling Safeway Select French Salted Caramel (Fleur De Sel) Premium Ice Cream sold in all Safeway-owned stores from November 4, 2014 through December 5, 2014 due to the inclusion of an undeclared peanut allergen.

People who have an allergy or severe sensitivity to peanuts run the risk of a serious or life-threatening allergic reaction if they consume this product. The recalled product is in a 1.5 quart package and displays the following UPC Code and Best Before Date.

Product Name UPC Code Best Before Date
Safeway Select French Salted Carmel (Fleur De Sel) Premium Ice Cream 21130 08970 Nov 03 2015

The UPC Code is located on the side panel. The Best Before Date is located on the bottom of the package.

No illnesses or injuries have been reported. The recipe’s caramel cups ingredient was replaced with peanut butter cups due to a supply error.

The recalled Safeway Select French Salted Caramel (Fleur De Sel) Premium Ice Cream was sold in all Safeway, Carrs, Genuardi’s, Pak ‘N Save, Pavilions, Randalls, Tom Thumb and Vons stores throughout the United States.

Customers are asked to discard the product or return it to their local store for a full refund. Customers who have questions about the recall can contact Safeway at 1-877-SAFEWAY.